Quality Systems

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Articles

Vyalev, also known as Produodopa, has been approved in 35 countries, with more than 4200 patients having started treatment.

FDA Approves AbbVie Therapy for Adults with Advanced Parkinson’s Disease

As many as 30% of people living with severe hemophilia A develop inhibitors such as TFPI, which can be produced by the body’s immune response to clotting factors in replacement therapy, often limiting the effectiveness of that therapy.

CHMP Gives Positive Opinion to Novo Nordisk Hemophilia Treatment

Wainzua had been previously approved for use by patients with ATTRv-PN in the United States, under the brand name Wainua.

AstraZeneca’s Polyneuropathy Treatment Recommended for EU Approval

The new mechanism of action targets cholinergic receptors instead of the standard dopamine receptors.

FDA Approves Schizophrenia Treatment that Targets Cholinergic Receptors

The agency is recommending that the market authorization for Oxbryta (voxelotor) be suspended so that emerging data may be reviewed.

EMA Suspends Sickle Cell Disease Medicine

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Bio/pharma companies should be approaching their decarbonization journey as a strategic business move for the future as industry stakeholders are placing greater value on sustainability.

Strategic Decarbonization

Feliza Mirasol is the science editor for 

Phase III trial results showed that Imfinzi (durvalumab in combination with chemotherapy reduced the risk of recurrence, progression, or death by 32% in patients with resectable non-small cell lung cancer before and after surgery.

AstraZeneca’s Imfinzi Gets Expanded Indication in Lung Cancer on FDA Approval

PiaSky (crovalimab) has previously been approved in countries such as the United States and Japan for monthly, subcutaneous use that may be self-administered with adequate training.

Roche Treatment for Paroxysmal Nocturnal Hemoglobinuria Approved in EU

Opaganib was given orphan drug designation for the treatment of neuroblastoma in children, which is rare, but the most common infancy malignancy.

FDA Grants Orphan Drug Designation to RedHill’s Treatment for Neuroblastoma

In a 24-week study of patients with PAH, six-minute walking distance improved by an average of 40.8 meters, and risk of death or clinical worsening was reduced by 82%.

Regulatory Authority Actions